Regulatory Recon: CDC Hid Numerous Mishaps With Deadly Germs; High Priced Drugs to Blame for Rise in Medicare Part D Spending (5 January 2017)

Posted 05 January 2017 By Michael Mezher

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology (Nature)
  • Scientific Evidence and Financial Obligations to Ensure Access to Biosimilars for Cancer Treatment (JAMA)
  • Changing Face of Clinical Trials: The Large Pharmaceutical Company Perspective (NEJM)
  • US Spending More on Specialty Drugs Under Medicare (WSJ) (HHS OIG)
  • CDC keeps secret its mishaps with deadly germs (USA Today)
  • Cancer Death Rate Has Dropped 25% Since 1991 Peak (American Cancer Society)
  • Trump presses Democrats on Obamacare, urges bipartisan fix (NYTimes) (Reuters)
  • The Health Care Plan Trump Voters Really Want (NYTimes)
  • Republicans' 4-Step Plan to Repeal the Affordable Care Act (NYTimes)
  • Obamacare repeal would cost New York state at least $3.7 billion: governor (Reuters)
  • Senate Dems to force drug pricing votes next week (Politico)
  • You Wouldn't Be Lying About That, Would You? (In the Pipeline)
  • Screen-And-Treat to Prevent Diabetes Doomed to Fail (CardioBrief)
  • Common morning sickness drug may not work (Reuters) (Washington Post)
  • Early Alzheimer's Gene Spells Tragedy For Patients, Opportunity For Science (KHN)
  • A Genetically Modified Malaria Vaccine Has Passed an Important Hurdle (MIT Technology Review)
  • First Circuit Rejects Whistleblower's Fraud on the FDA FCA Theory (Ropes & Gray)
  • Synthetic Biologics' C. difficile mid-stage study meets main goal (Reuters)
  • Heron drug for post-surgery pain succeeds in midstage trial (Reuters) (Press)
  • Eli Lilly chief seeks to recover from Alzheimer's drug flop (Financial Times) (Nature)
  • FDA to Further Study Deceptive Drug Advertising (Focus)
  • New FDA Drug Approvals: Breaking Down the Numbers (Focus)
  • Bipartisan House Bill Seeks to Repeal Medical Device Tax (Focus)
  • Alexion Says Senior Management Improperly Pressured Staff to Boost Sales (WSJ)
  • The FDA's position on social media By Dr Nicola Davies (PharmaLetter-$)
  • Generic Application Quality Showing Signs Of Improvement (Pink Sheet-$)
  • Priority review in the US for Bayer's liver cancer drug (PharmaTimes)
  • US OKs CV death risk reduction data for empagliflozin (PharmaTimes)
  • Abbott closes $25B St. Jude buy (MassDevice)

In Focus: International

  • European Regulatory Roundup: Swissmedic Clarifies Stance on EC Certificates for Devices (Focus)
  • MHRA Inspectorate: Helping us to help you (MHRA)
  • NHS to trial artificial intelligence app in place of 111 helpline (Financial Times) (The Verge)
  • Taking auditing to new level with International Standard under revision (ISO)
  • Swiss Competent Authority Weighs in on Medical Device Firms "Orphaned" by their Notified Bodies (Emergo)
  • 2022 deadline likely as Brazil enacts drug traceability law (Securing Industry)
  • Focus Intensifying in Europe on Improving Drug/Device Combination Product Regulatory Communication (IPQ)
  • Record Fine For Pfizer Throws Spotlight On UK Generic Pricing (Pink Sheet-$)

US: Pharmaceuticals & Biotechnology

  • Biden to tackle broad range of cancer issues, including drug prices, after leaving White House (Washington Post)
  • The 'final nail in the coffin' for Aids? (Financial Times)
  • Why Alexion Pharmaceuticals Is Overvalued (Forbes)
  • US scientists fear new restrictions on fetal-tissue research (Nature)
  • Early Stage Biopharma Financings Kept Up Multibillion-Dollar Pace In 2016 (SCRIP-$)
  • One scientist's seven-year odyssey to commercialize his drug, by trial and (a lot of) error (STAT)
  • J&J in New Year deal mania, takes on NASH candidate with biotech buyout option (Fierce)
  • What Pharma and Health Care Investors Should Watch for at JPM (The Street)
  • Oligonucleotide Therapeutics — A New Class of Cholesterol-Lowering Drugs (NEJM)
  • Three imminent second chances in first-line lung cancer (EP Vantage)
  • A Peer Recovery Coach Walks The Frontlines Of The Opioid Epidemic (KHN)
  • Brand vs. Brand Patent Battles Heat Up, Focus On Big Drug Classes (Pink Sheet-$)
  • Lilly to Adjust Organization and Leadership Structure to Better Align with Growth Opportunities (Press)
  • FDA to Review Liletta Use for Up to 4 Years (MPR)
  • Walgreens Expects 2017 Rebound As New PBM Deals Take From CVS (Forbes)
  • Bicycle Therapeutics Appoints Nicholas Keen, Ph.D., as Chief Scientific Officer (Press)
  • Bristol-Myers Squibb Announces Immunotherapy Clinical Collaboration with Janssen to Evaluate Opdivo (nivolumab) in Combination with Darzalex (daratumumab) (Press)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Halozyme's pancreatic cancer drug succeeds in mid-stage trial (Reuters)
  • Lycera's double-action immuno-oncology drug starts trials (Fierce)
  • Neurelis wins fast track designation from FDA for intranasal diazepam spray (MassDevice)
  • Seattle Genetics Initiates Phase 1 Trial of SGN-CD352A for Patients with Relapsed or Refractory Multiple Myeloma (Press)
  • Cellectis Files IND For Talen-Edited 'Off-The-Shelf' CAR-T Candidate (SCRIP-$)
  • Sangamo BioSciences Announces FDA Clearance Of Investigational New Drug Application For SB-525 Gene Therapy Program For Hemophilia A (Press)
  • XTL Biopharmaceuticals' Preclinical Studies of hCDR1 Demonstrate Therapeutic Potental In the Treatment of Sjögren's Syndrome (Press)
  • Vermillion and ASPiRA LABS Announce Receipt of Formal FDA Clarification Regarding Ovarian Cancer Screening Alert (Press)
  • Catabasis Pharmaceuticals Research on CAT-5571, a Novel Activator of Autophagy and Potential Oral Treatment for Cystic Fibrosis, Published in Journal of Medicinal Chemistry (Press)
  • Agile's Phase III Data For Twirla Patch Fall Flat, Raise Doubts On Approval (Pink Sheet-$)
  • U.S. FDA approves supplemental New Drug Applications to include landmark data in product labels for Synjardy® (empagliflozin/metformin hydrochloride), Synjardy® XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi® (empagliflozin/linagliptin) tablets (Press)
  • Keystone Nano Announces FDA Approval Of Investigational New Drug Application For Ceramide NanoLiposome For The Improved Treatment Of Cancer (Press)

US: Medical Devices

  • GE plans to dominate 3D printing: Here's how (MassDevice)
  • January 2017- DITTA Report Underlines Commitment To Cybersecurity (MITA)
  • Flashback Technologies wins de novo FDA nod for blood loss algorithm (MassDevice)
  • Luminex Gets FDA Clearance for Aries GBS Assay (GenomeWeb)
  • Connected medical devices put healthcare at risk for sophisticated malware attacks (Fierce)

US: Assorted & Government

  • Janssen Files Supplemental Brief In Infliximab Litigation (Big Molecule Watch)
  • Food and Drug Administration Tribal Consultation Policy; Availability (FDA)
  • Finding Conflict, Chief Justice Leaves Patent-Export Case (Law360-$)
  • Teva Ducks Whistleblower's Off-Label Marketing FCA Suit (Law360-$)
  • Actavis, Mylan, Teva Rigged Cholesterol Drug Price, Suit Says (Law360-$)
  • The ACA Transformed Medicaid Enrollment Processes. Rolling Them Back Would Wreak Havoc. (Health Affairs Blog)
  • Appeals court upholds Patent Office's invalidity ruling on J&J stents patent (MassDevice)
  • Express Warranty Claim Preempted (Drug & Device Law)
  • Louisiana Lawyers Sue Milberg Over Vioxx Fees, Seek Up To $10.6 Million (Forbes)
  • J&J Says Pfizer Unit Jointly Liable In Remicade Patent Suit (Law360-$)

Upcoming Meetings & Events

Asia

  • China confirms latest human death from H7N9 bird flu (Reuters)
  • Eisai Acquires All Global Development And Marketing Rights For Chronic Weight Management Treatment Lorcaserin (Press)

India

  • DoP directs NPPA to re-fix ceiling price of ondansetron 2 mg/ml injectables (PharmaBiz)

Canada

  • Canadian nod for Sobi's drug in rare genetic disorder (PharmaLetter-$)

Australia

  • Update on compliance verification GMP clearance applications (TGA)

General Health & Other Interesting Articles

  • Feed Your Kids Peanuts, Early and Often, New Guidelines Urge (NYTimes)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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